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ITMI20072051A1 - PELLET BASED COMPOSITION OF LIPOIC ACID - Google Patents

PELLET BASED COMPOSITION OF LIPOIC ACID Download PDF

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Publication number
ITMI20072051A1
ITMI20072051A1 IT002051A ITMI20072051A ITMI20072051A1 IT MI20072051 A1 ITMI20072051 A1 IT MI20072051A1 IT 002051 A IT002051 A IT 002051A IT MI20072051 A ITMI20072051 A IT MI20072051A IT MI20072051 A1 ITMI20072051 A1 IT MI20072051A1
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IT
Italy
Prior art keywords
composition according
medium
lipoic acid
hyipophilic
active
Prior art date
Application number
IT002051A
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Italian (it)
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Chimico Internaz S P A In Brev
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Publication date
Application filed by Chimico Internaz S P A In Brev filed Critical Chimico Internaz S P A In Brev
Priority to IT002051A priority Critical patent/ITMI20072051A1/en
Priority to AT08840866T priority patent/ATE506053T1/en
Priority to RS20110249A priority patent/RS51712B/en
Priority to CA2703152A priority patent/CA2703152C/en
Priority to US12/739,449 priority patent/US9820948B2/en
Priority to CN2008801173655A priority patent/CN101861144B/en
Priority to DK08840866.1T priority patent/DK2217220T3/en
Priority to PL08840866T priority patent/PL2217220T3/en
Priority to SI200830241T priority patent/SI2217220T1/en
Priority to JP2010530581A priority patent/JP5626890B2/en
Priority to KR1020107010844A priority patent/KR101599078B1/en
Priority to MX2010004481A priority patent/MX2010004481A/en
Priority to AU2008315667A priority patent/AU2008315667B2/en
Priority to BRPI0816587-4A2A priority patent/BRPI0816587A2/en
Priority to NZ584884A priority patent/NZ584884A/en
Priority to HR20110453T priority patent/HRP20110453T1/en
Priority to EP08840866A priority patent/EP2217220B1/en
Priority to PT08840866T priority patent/PT2217220E/en
Priority to UAA201006077A priority patent/UA100394C2/en
Priority to ES08840866T priority patent/ES2363880T3/en
Priority to PCT/IB2008/002835 priority patent/WO2009053824A1/en
Priority to DE602008006454T priority patent/DE602008006454D1/en
Priority to RU2010120706/15A priority patent/RU2501558C2/en
Publication of ITMI20072051A1 publication Critical patent/ITMI20072051A1/en
Priority to TN2010000163A priority patent/TN2010000163A1/en
Priority to ZA2010/02777A priority patent/ZA201002777B/en
Priority to IL205211A priority patent/IL205211A/en
Priority to CY20111100670T priority patent/CY1112122T1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4875—Compounds of unknown constitution, e.g. material from plants or animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A61P39/02—Antidotes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A61P39/06—Free radical scavengers or antioxidants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
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  • Urology & Nephrology (AREA)
  • Communicable Diseases (AREA)
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  • Biochemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Fodder In General (AREA)
  • Meat, Egg Or Seafood Products (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

The present invention concerns a new composition based on pellets of lipoic acid in a lipophilic medium, if necessary combined with other active ingredients.

Description

edibile. Miscele di veicoli o componenti lipofili possono altresì essere utilizzate. edible. Vehicle mixtures or lipophilic components can also be used.

Secondo un aspetto preferito della presente invenzione, il mezzo lipofilo è un componente lipofilo avente delle proprietà benefiche per l’organismo umano o animale, ad esempio delle proprietà antiossidanti o di regolazione del metabolismo dei grassi. According to a preferred aspect of the present invention, the lipophilic medium is a lipophilic component having beneficial properties for the human or animal organism, for example antioxidant or fat metabolism regulation properties.

In alternativa, il mezzo lipofilo può essere un mezzo inerte, farmaceuticamente accettabile o comunque edibile, il cui solo scopo è veicolare i pellet di acido lipoico e degli altri eventuali principi attivi. Alternatively, the lipophilic medium can be an inert, pharmaceutically acceptable or in any case edible medium, the sole purpose of which is to convey the pellets of lipoic acid and any other active ingredients.

Qualora il mezzo lipofilo sia un componente lipofilo inerte, ad esempio un olio alimentare, la composizione dell’ invenzione comprenderà preferibilmente anche un altro principio attivo. If the lipophilic medium is an inert lipophilic component, for example an edible oil, the composition of the invention will preferably also include another active ingredient.

Secondo una forma di realizzazione vantaggiosa di questo aspetto dell’invenzione, il mezzo lipofilo è folio di pesce, in particolare EPA (acido (5Z,8Z,1 lZ,14Z,l7Z)-5,8,l l,14,17-eicosapentaenoico) e DMA (acido 4Z,7Z,10Z,13Z,16Z,19Z)-4,7,10,13,16,19-Docosaesaenoico) o gli oli conosciuti con la denominazione Omega 3. According to an advantageous embodiment of this aspect of the invention, the lipophilic medium is fish folio, in particular EPA ((5Z, 8Z, 1 1Z, 14Z, 17Z) -5.8,1,1,14,17-eicosapentaenoic acid ) and DMA (4Z, 7Z, 10Z, 13Z, 16Z, 19Z acid) -4,7,10,13,16,19-Docosahexaenoic) or oils known as Omega 3.

Le composizioni dell’invenzione sono vantaggiosamente formulate in unità di dosaggio sotto fonna di capsule di gelatina, dure o molli, queste ultime essendo particolarmente preferite. The compositions of the invention are advantageously formulated in dosage units in the form of hard or soft gelatin capsules, the latter being particularly preferred.

Dette unità di dosaggio possono contenere ad esempio da 10 a 1000 mg di acido lipoico, preferibilmente da 100 a 600 mg, ad esempio circa 200, 300, 400 o 500 ing. Said dosage units can contain for example from 10 to 1000 mg of lipoic acid, preferably from 100 to 600 mg, for example about 200, 300, 400 or 500 ing.

Il mezzo lipofilo può essere contenuto nelle dette unità di dosaggio in quantità variabili, ad esempio nel caso delle capsule, a seconda delle dimensioni della capsula. The lipophilic medium can be contained in said dosage units in variable quantities, for example in the case of capsules, according to the size of the capsule.

Quando il mezzo lipofilo è un componente lipofilo avente delle proprietà benefiche per l’organismo umano o animale, tale componente è presente nelle quantità normalmente utilizzate nelle pratica dietetica e terapeutica convenzionale. When the lipophilic medium is a lipophilic component having beneficial properties for the human or animal organism, this component is present in the quantities normally used in conventional dietary and therapeutic practices.

Ad esempio, quando il mezzo lipofilo è l’olio di pesce, detto componente può essere presente in quantità comprese tra 100 e 1000 mg, preferibilmente tra 500 e 800 mg. Vantaggiosamente lolio di pesce conterrà non meno del 60% di EPA e DHA, in rapporto reciproco variabile, preferibilmente in rapporto di circa 2:1. For example, when the lipophilic medium is fish oil, said component can be present in quantities ranging from 100 to 1000 mg, preferably between 500 and 800 mg. Advantageously, the fish oil will contain not less than 60% of EPA and DHA, in a variable reciprocal ratio, preferably in a ratio of about 2: 1.

Quando il mezzo lipofilo è Omega 3, detto componente può essere presente in quantità comprese tra 100 e 3000 mg o anche più. When the lipophilic medium is Omega 3, said component can be present in quantities ranging from 100 to 3000 mg or even more.

Le dette unità di dosaggio sono preferibilmente assunte per via orale, una o più volte al giorno. Said dosage units are preferably taken orally, one or more times a day.

Nella composizione dell’invenzione, i pellet di acido lipoico si disperdono nel mezzo lipofilo, pur mantenendo la loro integrità fisica, e la composizione risultante è particolarmente stabile. La composizione che si ottiene è pertanto una miscela di pellet di acido lipoico e mezzo lipofilo. In the composition of the invention, the lipoic acid pellets are dispersed in the lipophilic medium, while maintaining their physical integrity, and the resulting composition is particularly stable. The resulting composition is therefore a mixture of lipoic acid pellets and a lipophilic medium.

Secondo un aspetto particolarmente preferito, l’invenzione ha per oggetto una composizione in forma di capsula di gelatina, preferibilmente molle, comprendente i pellet di acido lipoico o dei suoi sali, come sopra definiti, e un componente lipofilo scelto tra l’olio di pesce, gli Omega 3 e le loro miscele. According to a particularly preferred aspect, the invention relates to a composition in the form of a gelatin capsule, preferably soft, comprising pellets of lipoic acid or its salts, as defined above, and a lipophilic component selected from fish oil , Omega 3s and their blends.

La composizione dell’invenzione ha un effetto antiossidante ed è utile per il trattamento dello stress ossidativo e, in ogni caso, di tutte le patologie per le quali l’acido lipoico è indicato. The composition of the invention has an antioxidant effect and is useful for the treatment of oxidative stress and, in any case, of all the diseases for which lipoic acid is indicated.

L’uso della composizione dell’ invenzione per la preparazione di un medicamento per il trattamento dello stress ossidativo costituisce un ulteriore oggetto della presente invenzione. The use of the composition of the invention for the preparation of a medicament for the treatment of oxidative stress constitutes a further object of the present invention.

La composizione dell’invenzione può contenere anche altri principi attivi, vantaggiosamente uno o due ulteriori principi attivi, purché stabili in ambiente Hpofilo. The composition of the invention may also contain other active ingredients, advantageously one or two additional active ingredients, as long as they are stable in the Hpofilo environment.

Grazie infatti alla presenza del mezzo iipofìio, le interazioni tra l’acido lipoico e gli altri principi attivi eventualmente presenti sono fortemente ridotte, con enorme vantaggio per la stabilità della composizione. Il fatto che l’acido lipoico sia in forma di pellet rivestiti diminuisce ulteriormente il rischio di interazioni e di degradazione dei componenti. Questo rappresenta come si comprenderà un importante progresso tecnico per la formulazione di principi attivi ad esempio poco stabili, poco solubili o molto reattivi. In fact, thanks to the presence of the hyipophy medium, the interactions between lipoic acid and other active ingredients that may be present are greatly reduced, with an enormous advantage for the stability of the composition. The fact that lipoic acid is in the form of coated pellets further decreases the risk of interactions and degradation of the components. This represents how it will be understood an important technical progress for the formulation of active principles, for example not very stable, not very soluble or very reactive.

Detti ulteriori principi attivi sono ad esempio scelti tra gli antidolorifici, i farmaci attivi nella neuropatia diabetica, gli epatoprotettori, i fannaci attivi nella prevenzione dell’abuso dì alcool, ì farmaci attivi nella terapia di supporto contro lo stress ossidativo generato dalla chemioterapia, gli antagonisti delfangiotensina II, gli ÀCE inibitori, gli antivirali, gli antitumorali e gli antidepressivi, purché come detto siano stabili in ambiente lipofilo. Said additional active ingredients are for example chosen from painkillers, drugs active in diabetic neuropathy, hepatoprotectors, drugs active in the prevention of alcohol abuse, drugs active in support therapy against oxidative stress generated by chemotherapy, antagonists delfangiotensin II, ACE inhibitors, antivirals, antitumors and antidepressants, provided that, as mentioned, they are stable in a lipophilic environment.

Dei principi attivi possono ad esempio essere scelti tra gabapentina, pregabalin, olmesartan captopril, interferone, aeamprosato e megestrolo. Active ingredients can for example be selected from gabapentine, pregabalin, olmesartan captopril, interferon, aeamprosate and megestrol.

Ancora possono essere inclusi nelle composizioni dell’invenzione componenti ad azione antiossidante, quali ad esempio acetilcisteina, acetil-1-camitina, al fa -tocoferolo (vitamina E) acetato, beta carotene biotìna boro clorofilla, crisina, Lycopodium e suoi estratti, flavonoidi del cacao, coenzima Q10, acido linoleico coniugato, rame, Coptis chinensis detto anche huang Han„ curcuminoidi, daidzeina, liquirizia, inclusi i suoi estratti privati di glicirrizina, dimetil solfossido, acido docosoesanoico (DHA), olii di pesce in generale, (merluzzo, aringa, tonno, salmone, etc.) Olio di Enotera (Oenothera Biennis, Primula notturna), olio di semi di lino, folati, gamma-tocoferolo, aglio, genisteina, germanio, gìnseng, glucosammina, derivati peptidici della glutammina, glutatione, glieina, gficiteina, olio di semi d’uva (olio di vinacciolo), proantcocianidìne di uva, catechine di te verde, estratti o parti della viola tricolore ( Viola tricolor), olio di canapa, esperetina, esperidina, idrossietilrutosidi, indol-3-carbinolo, inositol esafosfato, lattoferrina, lattulosio, 1-argìnina, 1-camitina, 1-cisteina, 1-eistidina, I-metionina. 1-teanina, licopene, manganese, melatonina, estratti o parti del cardo mariano (Sylibum marianum), nicotinammide, pantetina, acido pantotenico,, propoli, semi di zucca, picnogenol (estratto pino marittimo), piruvato, quercitina, resveratrolo, ribofiavina vitamina B2, ratina, secoisolariciresinolo, diglucoside (sdg), selenio, cartilagine di squalo, isoflavoni della soia, proteine della soia, spirulina, Sulforafano (derivato della glucorafanina), taurina, tiamina (vitamina Bl), tocotrienoli, vinpocetina, vitamina A, vitamina B6, vitamina C, vitamina D, vitamina E, vitamina K, grano/malto c loro derivati, proteine del siero e zinco. Also included in the compositions of the invention are components with antioxidant action, such as for example acetylcysteine, acetyl-1-camitine, phatocopherol (vitamin E) acetate, beta carotene biotine boron chlorophyll, chrysin, Lycopodium and its extracts, flavonoids of the cocoa, coenzyme Q10, conjugated linoleic acid, copper, Coptis chinensis also called huang Han, curcuminoids, daidzein, licorice, including its private extracts of glycyrrhizin, dimethyl sulfoxide, docosohexanoic acid (DHA), fish oils in general, (cod, herring, tuna, salmon, etc.) Evening primrose oil (Oenothera Biennis, Night primrose), linseed oil, folate, gamma-tocopherol, garlic, genistein, germanium, gìnseng, glucosamine, peptide derivatives of glutamine, glutathione, gliein , gficitein, grape seed oil (grape seed oil), grape proanthocyanidins, green tea catechins, extracts or parts of viola tricolor (Viola tricolor), hemp oil, hesperetin, hesperidin, hydroxy ethylrutosides, indole-3-carbinol, inositol hexaphosphate, lactoferrin, lactulose, 1-arginine, 1-camitine, 1-cysteine, 1-eistidine, I-methionine. 1-theanine, lycopene, manganese, melatonin, extracts or parts of milk thistle (Sylibum marianum), nicotinamide, pantethine, pantothenic acid, propolis, pumpkin seeds, picnogenol (maritime pine extract), pyruvate, quercetin, resveratrol, vitamin ribofiavina B2, ratin, secoisolariciresinol, diglucoside (sdg), selenium, shark cartilage, soy isoflavones, soy protein, spirulina, sulforaphane (derivative of glucoraphanine), taurine, thiamine (vitamin Bl), tocotrienols, vinpocetine, vitamin A, vitamin B6, vitamin C, vitamin D, vitamin E, vitamin K, wheat / malt and their derivatives, whey proteins and zinc.

Le unità di dosaggio comprendenti la composizione dell’invenzione costituiscono un ulteriore oggetto della presente invenzione. The dosage units comprising the composition of the invention constitute a further object of the present invention.

Le composizioni e le unità di dosaggio dell’invenzione sono preparate secondo i metodi noti. The compositions and dosage units of the invention are prepared according to known methods.

Le composizioni dell’ invenzione possono essere preparate per miscelazione dei vari componenti, per esempio aggiungendo i vari componenti al mezzo lipofilo prescelto. The compositions of the invention can be prepared by mixing the various components, for example by adding the various components to the selected lipophilic medium.

Le unità di dosaggio secondo l’invenzione sono preparate usando la composizione dell’invenzione secondo le tecniche ben note alla tecnica. The dosage units according to the invention are prepared using the composition of the invention according to the techniques well known to the art.

SEZIONE SPERIMENTALE EXPERIMENTAL SECTION

Esempio l Example l

Si prepara una capsula di gelatina molle contenente: A soft gelatin capsule is prepared containing:

acido lipoico in forma di pellet 300 mg lipoic acid in the form of pellets 300 mg

olio di pesce 500 mg fish oil 500 mg

Esempio 2 Example 2

Si prepara una capsula di gelatina molle contenente: A soft gelatin capsule is prepared containing:

acido lipoico in forma di pellet 500 mg lipoic acid in the form of pellets 500 mg

olio di pesce 800 mg fish oil 800 mg

Esempio 3 Example 3

Si prepara una capsula di gelatina molle contenente: A soft gelatin capsule is prepared containing:

acido lipoico in forma di pellet 400 mg lipoic acid in the form of pellets 400 mg

Omega 3 2000 mg Omega 3 2000 mg

Esempio 4 Example 4

Si prepara una capsula di gelatina molle contenente: A soft gelatin capsule is prepared containing:

acido lipoico in forma di pellet 300 mg lipoic acid in the form of pellets 300 mg

olio di pesce 700 mg fish oil 700 mg

gabapentina 300 mg gabapentine 300 mg

Esempio 5 Example 5

Si prepara una capsula di gelatina molle contenente: A soft gelatin capsule is prepared containing:

acido lipoico in forma di pellet 300 mg lipoic acid in the form of pellets 300 mg

olio di pesce 700 mg pregabalin 120 mg Esempio 6 fish oil 700 mg pregabalin 120 mg Example 6

Si prepara una capsula di gelatina molle contenente; acido lipoico in forma di pellet 300 mg A soft gelatin capsule is prepared containing; lipoic acid in the form of pellets 300 mg

olio di pesce 700 mg gabapentina 300 mg coenzima Q 10 30 mg Esempio 7 fish oil 700 mg gabapentine 300 mg coenzyme Q 10 30 mg Example 7

Si prepara una capsula di gelatina molle contenente: acido lipoico in forma di pellet 200 mg coenzima Q10 30 mg olio vegetale q.b. A soft gelatin capsule is prepared containing: lipoic acid in the form of pellets 200 mg coenzyme Q10 30 mg vegetable oil q.s.

Claims (17)

RIVENDICAZIONI 1. Composizione comprendente pellet di acido lipoico, o di un suo sale, veicolati in almeno un mezzo iipofilo. CLAIMS 1. Composition comprising pellets of lipoic acid, or of a salt thereof, carried in at least one hyipophilic medium. 2. Composizione secondo la rivendicazione 1, caratterizzata dal fatto che detto mezzo Iipofilo è un componente Iipofilo avente delle proprietà benefiche per l’organismo umano o animale. 2. Composition according to claim 1, characterized in that said hyipophilic medium is a hyipophilic component having beneficial properties for the human or animal organism. 3. Composizione secondo la rivendicazione 2, caratterizzata dal fatto che detto mezzo Iipofilo ha proprietà antiossidanti. 3. Composition according to claim 2, characterized in that said hypophilic medium has antioxidant properties. 4. Composizione secondo la rivendicazione 3, caratterizzata dal fatto che detto mezzo Iipofilo è scelto tra olio di pesce, EPA, DHA, Omega 3 e le loro miscele. 4. Composition according to claim 3, characterized in that said hyipophilic medium is selected from fish oil, EPA, DHA, Omega 3 and their mixtures. 5. Composizione secondo la rivendicazione I, caratterizzata dal fatto che detto mezzo Iipofilo è un componente Iipofilo inerte, farmaceuticamente accettabile e/o edibile. 5. Composition according to claim I, characterized in that said hypophilic medium is an inert, pharmaceutically acceptable and / or edible hyipophilic component. 6. Composizione secondo una qualsiasi delle rivendicazioni precedenti, caratterizzata dal fatto che è in forma di unità di dosaggio. 6. Composition according to any one of the preceding claims, characterized in that it is in the form of a dosage unit. 7. Composizione secondo la rivendicazione 6, caratterizzata dal fatto che è in forma di capsule di gelatina. 7. Composition according to claim 6, characterized in that it is in the form of gelatin capsules. 8. Composizione secondo una qualsiasi delle rivendicazioni 6 o 7, caratterizzata dal fatto che contiene da 10 a 1000 mg di acido lipoico. 8. Composition according to any one of claims 6 or 7, characterized in that it contains from 10 to 1000 mg of lipoic acid. 9. Composizione secondo la rivendicazione 8, caratterizzata dal fatto che contiene da 100 a 600 mg di acido lipoico. 9. Composition according to claim 8, characterized in that it contains from 100 to 600 mg of lipoic acid. 10. Composizione secondo una qualsiasi delle rivendicazioni da 6 a 9, caratterizzata dal fatto che contiene tra 100 e 1000 mg di olio di pesce. Composition according to any one of claims 6 to 9, characterized in that it contains between 100 and 1000 mg of fish oil. 1 1. Composizione secondo una qualsiasi delle rivendicazioni da 6 a 9, caratterizzata dal fatto che contiene tra 100 e 3000 mg di Omega 3. 1 1. Composition according to any one of claims 6 to 9, characterized in that it contains between 100 and 3000 mg of Omega 3. 12. Composizione secondo una qualsiasi delle rivendicazioni precedenti, caratterizzata dal fatto che comprende anche un principio attivo scelto tra antidolorifici, i farmaci attivi nella neuropatia diabetica, gii epatoprotcttorì, i farmaci attivi nella prevenzione dell’abuso di alcool, i farmaci attivi nella terapia di supporto contro lo stress ossidativo generato dalla chemioterapia, gli antagonisti deH’angiotensina II, gli ACE inibitori, gli antivirali, gii antitumorali e gli antidepressivi, a condizione che sia stabile in ambiente lipofilo. 12. Composition according to any one of the preceding claims, characterized in that it also comprises an active ingredient selected from painkillers, drugs active in diabetic neuropathy, hepatoprotectors, drugs active in the prevention of alcohol abuse, drugs active in the therapy of support against oxidative stress generated by chemotherapy, angiotensin II antagonists, ACE inhibitors, antivirals, anticancer drugs and antidepressants, provided that it is stable in a lipophilic environment. 13. Composizione secondo una qualsiasi delle rivendicazioni da 1 a 11, caratterizzata dal fatto che comprende anche un principio attivo scelto tra gabapentina, pregabalin, olmesartan captopril, interferone, acamprosato e megestrolo. 13. Composition according to any one of claims 1 to 11, characterized in that it also comprises an active principle selected from gabapentine, pregabalin, olmesartan captopril, interferon, acamprosate and megestrol. 14. Composizione secondo una qualsiasi delle rivendicazioni da ! a 11, caratterizzata dal fatto che comprende anche un principio attivo ad azione antiossidante. 14. Composition according to any one of claims from! a 11, characterized by the fact that it also includes an active ingredient with antioxidant action. 15. Uso di una composizione secondo una qualsiasi delle rivendicazioni precedenti per la preparazione dì un medicamento per il trattamento dello stress ossidativo. 15. Use of a composition according to any one of the preceding claims for the preparation of a medicament for the treatment of oxidative stress. 16. Unità di dosaggio comprendente la composizione secondo una qualsiasi delle rivendicazioni da 1 a 14. A metering unit comprising the composition according to any one of claims 1 to 14. 17. Unità di dosaggio secondo la rivendicazione 16 che è una capsula di gelatina.17. A dosage unit according to claim 16 which is a gelatin capsule.
IT002051A 2007-10-23 2007-10-23 PELLET BASED COMPOSITION OF LIPOIC ACID ITMI20072051A1 (en)

Priority Applications (27)

Application Number Priority Date Filing Date Title
IT002051A ITMI20072051A1 (en) 2007-10-23 2007-10-23 PELLET BASED COMPOSITION OF LIPOIC ACID
PCT/IB2008/002835 WO2009053824A1 (en) 2007-10-23 2008-10-23 Lipoic acid pellet composition
BRPI0816587-4A2A BRPI0816587A2 (en) 2007-10-23 2008-10-23 Lipoic Acid PELLET COMPOSITION, USE OF A COMPOSITION AND DOSING UNIT
CA2703152A CA2703152C (en) 2007-10-23 2008-10-23 Lipoic acid pellet composition
US12/739,449 US9820948B2 (en) 2007-10-23 2008-10-23 Lipoic acid pellet composition
CN2008801173655A CN101861144B (en) 2007-10-23 2008-10-23 Lipoic acid pellet composition
DK08840866.1T DK2217220T3 (en) 2007-10-23 2008-10-23 Composition of Lipoic Acid Pellets
PL08840866T PL2217220T3 (en) 2007-10-23 2008-10-23 Lipoic acid pellet composition
SI200830241T SI2217220T1 (en) 2007-10-23 2008-10-23 Lipoic acid pellet composition
JP2010530581A JP5626890B2 (en) 2007-10-23 2008-10-23 Lipoic acid pellet composition
KR1020107010844A KR101599078B1 (en) 2007-10-23 2008-10-23 Lipoic acid pellet composition
MX2010004481A MX2010004481A (en) 2007-10-23 2008-10-23 Lipoic acid pellet composition.
HR20110453T HRP20110453T1 (en) 2007-10-23 2008-10-23 LIPOIC ACID PELLET COMPOSITION
AT08840866T ATE506053T1 (en) 2007-10-23 2008-10-23 COMPOSITION OF LIPONIC ACID PELLETS
NZ584884A NZ584884A (en) 2007-10-23 2008-10-23 1,2-dithiolan-3-pentanoic acid or thioctic acid pellets
AU2008315667A AU2008315667B2 (en) 2007-10-23 2008-10-23 Lipoic acid pellet composition
EP08840866A EP2217220B1 (en) 2007-10-23 2008-10-23 Lipoic acid pellet composition
PT08840866T PT2217220E (en) 2007-10-23 2008-10-23 Lipoic acid pellet composition
UAA201006077A UA100394C2 (en) 2007-10-23 2008-10-23 Lipoic acid pellet composition
ES08840866T ES2363880T3 (en) 2007-10-23 2008-10-23 COMPOSITION OF LIPOIC ACID MICROGRANULES.
RS20110249A RS51712B (en) 2007-10-23 2008-10-23 LIPOIC ACID PELLET COMPOSITION
DE602008006454T DE602008006454D1 (en) 2007-10-23 2008-10-23 COMPOSITION OF LIPONIC ACID PELLETS
RU2010120706/15A RU2501558C2 (en) 2007-10-23 2008-10-23 Ball-shaped lipoic acid composition
TN2010000163A TN2010000163A1 (en) 2007-10-23 2010-04-15 Lipoic acid pellet composition
ZA2010/02777A ZA201002777B (en) 2007-10-23 2010-04-20 Lipoic acid pellet composition
IL205211A IL205211A (en) 2007-10-23 2010-04-21 Lipoic acid pellet composition
CY20111100670T CY1112122T1 (en) 2007-10-23 2011-07-11 COMPOSITION OF Lipoic acid bullet

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AT (1) ATE506053T1 (en)
AU (1) AU2008315667B2 (en)
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CA (1) CA2703152C (en)
CY (1) CY1112122T1 (en)
DE (1) DE602008006454D1 (en)
DK (1) DK2217220T3 (en)
ES (1) ES2363880T3 (en)
HR (1) HRP20110453T1 (en)
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MX (1) MX2010004481A (en)
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ES2363880T3 (en) 2011-08-18
WO2009053824A1 (en) 2009-04-30
ZA201002777B (en) 2011-06-29
BRPI0816587A2 (en) 2015-03-03
RS51712B (en) 2011-10-31
EP2217220A1 (en) 2010-08-18
CN101861144B (en) 2013-03-13
US20110129442A1 (en) 2011-06-02
ATE506053T1 (en) 2011-05-15
UA100394C2 (en) 2012-12-25
JP2011500784A (en) 2011-01-06
NZ584884A (en) 2011-11-25
AU2008315667B2 (en) 2013-02-28
EP2217220B1 (en) 2011-04-20
US9820948B2 (en) 2017-11-21
CA2703152A1 (en) 2009-04-30
PL2217220T3 (en) 2011-09-30
CY1112122T1 (en) 2015-11-04
RU2501558C2 (en) 2013-12-20
KR20100089848A (en) 2010-08-12
DK2217220T3 (en) 2011-08-01
KR101599078B1 (en) 2016-03-02
SI2217220T1 (en) 2011-06-30
CN101861144A (en) 2010-10-13
MX2010004481A (en) 2010-08-02
IL205211A (en) 2013-01-31
HRP20110453T1 (en) 2011-07-31
DE602008006454D1 (en) 2011-06-01
TN2010000163A1 (en) 2011-11-11
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IL205211A0 (en) 2010-12-30

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